Mineralys Top Line Data Presentation: Launch-HTN and Advance-HTN Pivotal Trials

Published: 2025-03-11 09:47:19 ET MLYS

Targeting Aldosterone in the Treatment of Cardiorenal Diseases

L a u n c h - H T N & A d v a n c e - H T N To p l i n e D a t a

M a r c h 1 0 , 2 0 2 5

Agenda

Introduction Jon Congleton

Launch-HTN and Advance-HTN Data Dr. David Rodman, M.D.

Conclusion Jon Congleton

04Q&A

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Positive Topline Results from Launch -HTN and Advance -HTN

Launch-HTN 19.0 mmHg absolute, and 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office BP at end of treatment, week 12

Advance-HTN 7.9 mmHg placebo-adjusted reduction assessed by 24hr ABPM at end of treatment, week 12

Lorundrostat demonstrated a favorable safety and tolerability profile in both pivotal trials

Full results from Advance-HTN to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions

Confidential Property of Mineralys Therapeutics, Inc.

Launch-HTN Phase 3 Pivotal Trial Design

Real-World efficacy and safety trial of lorundrostat when added on top of 2-5 existing hypertension medications in uncontrolled and resistant hypertension, 1,083 subjects

2 weeks

12 weeks

Placebo Run-In

Double-Blind Treatment

Existing background antihypertensive treatment (2 to 5 meds)

Placebo QD

Fail to achieve

goal with AOBP on

Lorundrostat 50 mg QD

existing regimen

Lorundrostat 50 mg QD titrate to 100 mg QD

Up-titration @

week 6

if SBP ≥ 130 mmHg

End of Study

Primary efficacy

endpoint

Change from baseline in AOBP Sys BP at Week 6

Confidential Property of Mineralys Therapeutics, Inc.

Launch-HTN Robust, Statistically Significant Results

Real-World study, how practitioners would utilize lorundrostat in daily practice for uncontrolled and resistant HTN

u/r/HTN patients on existing regimen of 2-5 AHTs

(n=1,083) on 50 mg lorundrostat QD

Week 6

Week 12

0.0

Primary

Predefined

Endpoint

mmHg

-5.0

-9.1

Change

-10.0

(p<0.0001)

-11.7

SBP

(p<0.0001)

-15.0

-16.9

-19.0

-20.0

Absolute PBO-Adjusted

Safe and well tolerated with 1.1% and 1.5% hyperkalemia rate, in 50mg and 50mg to 100mg arms, respectively

Predefined

▪ Endpoint

~29% black

▪ ~47% female

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Launch-HTN Topline Safety Summary

Launch-HTN trial demonstrated that lorundrostat delivered a compelling safety profile

SAEs 0.7 % to 2.4%, TEAEs leading to dosing discontinuation 1.5% to 2.6%

Placebo

Lorundrostat

Total

50 mg QD

50 mg to 100 mg QD

N=270

N=1,078

N=538

N=270

Events

SAEs

3.3

2.4

0.7

2.2

TEAEs

36.3

202

53.7

289

636

55.9

151

313

49.9

538

1,151

Drug-Related

18.9

38.8

209

389

39.3

106

191

34.0

366

663

AESI

11.1

23.0

124

164

24.1

20.3

219

292

Leading to dosing discontinuation

1.9

2.6

1.5

2.1

Leading to death

0.0

SAEs: Serious Adverse Events; TEAEs: Treatment Emergent Adverse Events; AESI: Adverse

Events of Special Interest; N: Number of Subjects; Events: Number of Events

Confidential Property of Mineralys Therapeutics, Inc.

Advance -HTN Phase 2 Pivotal Trial Design

Confirmatory efficacy and safety trial of lorundrostat in uncontrolled and resistant hypertension, 285 subjects

3 weeks

Optimized AHT Regimen

Run-In

Randomization of subjects who fail to achieve BP goal during run-in

12 weeks

Double-Blind Treatment

Continue standardized background regimen*

Placebo QD

Lorundrostat 50 mg QD

Lorundrostat 50 mg QD titrate to 100 mg QD

Up-titration @

week 4

if SBP ≥ 130 mmHg

4 weeks

Washout

Blinded 4-week

Washout

Primary efficacy

endpoint

Change in 24h ABPM Sys BP from Week 0 to Week 12

*Start optimized drug background regimen. 2 AHTs = ARB + Diuretic / 3-5 AHTs = ARB + Diuretic + CCB

Confidential Property of Mineralys Therapeutics, Inc.

Advance -HTN Robust, Statistically Significant Results

Specialist driven trial, testing lorundrostat benefit when added to optimized background with 24 hr ABPM

Confirms 50mg QD dose

5.3% and 7.4% hyperkalemia rate, in 50mg and 50mg to 100mg arms, respectively

Full topline data at ACC.25

Previously noted demographics:

7.9*

mmHg

reduction

* Placebo adjusted.

Confidential Property of Mineralys Therapeutics, Inc.

Lorundrostat Development Program with Positive Pivotal Data and Market Expansion Proof -of-Concept Trials

Trial

Safety

Proof of Concept

Pivotal

Key Milestones

COMPLETED

-7.9mmHg PBO

uHTN & rHTN Standardized background AHT

adjusted

Hypertension

at week 12

-11.7mmHg PBO

COMPLETED

uHTN & rHTN Existing background AHT

adjusted

at week 12

Lorundrostat

Hypertension & Chronic Kidney Disease

CKD + HTN PoC & Profiling

Topline Data

(CKD)

2Q 2025

Obstructive Sleep Apnea (OSA) &

OSA + HTN PoC & Profiling

Initiated 1Q 2025

Hypertension

Open-Label Extension

uHTN & rHTN

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Disclaimer

Mineralys Therapeutics Inc. published this content on March 10, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 11, 2025 at 13:46:09.990.